Cementless Knee Replacement for Osteoarthritis

Not currently recruiting at 21 trial locations

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: DePuy Orthopaedics

Must not be taking: Muscular disorder medications

Disqualifiers: Pregnancy, Inflammatory arthritis, Neurological disorders, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 7

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new type of knee replacement for people with osteoarthritis, focusing on devices that don't use cement (Cementless Total Knee Arthroplasty). The researchers aim to assess improvements in movement and function two years after surgery. Two types of knee implants are being tested: one that preserves the natural knee ligaments and another that does not. This trial suits individuals diagnosed with osteoarthritis who are not bedridden and are suitable for this type of knee surgery.

As an unphased trial, this study offers a unique opportunity to contribute to innovative research in knee replacement technology.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, if you are taking prescription medications for a muscular disorder that limits mobility, you may not be eligible to participate.

What prior data suggests that this cementless knee replacement is safe for osteoarthritis patients?

Research has shown that cementless total knee replacement is generally safe and well-tolerated. Recent studies have found that modern cementless knee replacements perform as well as traditional cemented ones, ensuring the new knee remains stable and functions properly over time. Some reports suggest that cementless knee replacements might require fewer follow-up surgeries compared to the cemented type.

Additionally, cementless knee replacements provide strong, long-lasting support. This method has been used successfully for many years, offering patients confidence in its safety. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike traditional knee replacements that use bone cement to secure the implant, the cementless total knee arthroplasty offers a different approach. This treatment is unique because it allows the patient's bone to grow into the implant, potentially leading to a more natural integration and longer-lasting results. Researchers are excited about this method because it could reduce the complications associated with cement failure and improve the overall longevity of the knee replacement. This innovative approach might provide a more durable solution for those suffering from osteoarthritis.

What evidence suggests that the cementless knee replacement is effective for osteoarthritis?

Research has shown that cementless total knee replacement, under study in this trial, holds promise for people with osteoarthritis. Recent studies indicate that modern cementless knee replacements perform as well as cemented ones. One study found a 99% chance that the knee joint remains stable and problem-free for ten years. This suggests the knee replacement is effective and stays in place without requiring additional surgeries. Overall, cementless knee replacement can enhance knee function for those with arthritis. ^{1 6 7 8 9}

Who Is on the Research Team?

Sukhjeet Kaur

Principal Investigator

Sponsor GmbH

Are You a Good Fit for This Trial?

This trial is for men and women aged 22-80 who are not bedridden, can consent to the study, understand procedures, complete questionnaires in English or translations provided, diagnosed with non-inflammatory degenerative joint disease (NIDJD), and suitable for cementless knee replacement. Exclusions include recent participation in other trials, litigation involvement, inflammatory arthritis conditions, life expectancy under five years, pregnancy/lactation status among others.

Inclusion Criteria

I have been diagnosed with a non-inflammatory joint disease.

Subject is able to read, and comprehend the Informed Consent Document as well as complete the required PROs in either English or one of the available translations

I am between 22 and 80 years old.

Exclusion Criteria

I have pain from my spine that spreads to the limb getting knee replacement.

I am currently pregnant or breastfeeding.

I have had surgery on my knee before, like a partial replacement or other specific procedures.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Surgery and Initial Recovery

Participants undergo the ATTUNE Cementless Rotating Platform Total Knee Arthroplasty and initial recovery

6 weeks

1 visit (in-person)

Post-operative Assessment

Participants are assessed for post-operative outcomes using various patient-reported measures and radiographic evaluations

2 years

Multiple visits (in-person and virtual) at 6 weeks, 6 months, 1 year, and 2 years

Long-term Follow-up

Participants are monitored for long-term outcomes, including survivorship and adverse events

5 years

Annual visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Cementless Total Knee Arthroplasty

Trial Overview The ATTUNE Cementless Total Knee Arthroplasty (TKA) system's performance is being tested. Specifically looking at functional improvements two years after surgery using the KOOS questionnaire. It compares cruciate retaining rotating platform and posterior stabilized rotating platform configurations of the TKA system.

How Is the Trial Designed?

Group I: ATTUNE Cementless RP TKA Experimental Treatment 1 Intervention

Subjects will receive a cementless, rotating platform total knee arthroplasty

Cementless Total Knee Arthroplasty is already approved in United States, European Union for the following indications:

Approved in United States as Cementless Total Knee Arthroplasty for:

• Severe knee damage due to arthritis or injury
• Significant knee pain
• Younger patients with good bone quality

Approved in European Union as Cementless Total Knee Arthroplasty for:

• Severe knee damage due to arthritis or injury
• Significant knee pain
• Younger patients with good bone quality

Who Is Running the Clinical Trial?

DePuy Orthopaedics

Lead Sponsor

Trials

81

Recruited

26,000+

Massimo Calafiore

DePuy Orthopaedics

Chief Executive Officer since 2023

MBA from Harvard Business School

Dr. Michael Stein

DePuy Orthopaedics

Chief Medical Officer since 2023

MD from University of Michigan

Published Research Related to This Trial

In a study comparing cemented and uncemented fixation methods in total knee replacement involving 12-14 cases per group, cemented fixation showed significantly less component migration over 2 years compared to press-fit uncemented fixation.

While clinical outcomes at 2 years were similar, the uncemented groups reported more pain, indicating that cemented fixation may provide better stability and comfort in the Kinemax design of tibial components.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A comparison between cemented, press-fit, and HA-coated interfaces in Kinemax total knee replacement. Walker, PS., Sathasivam, S., Cobb, A., et al.[2019]

Uncemented total knee arthroplasty (TKA) has a significantly higher risk of implant failure due to aseptic loosening compared to cemented TKA, with odds ratios of 3.41 and 4.73 at 5 and 10 years, respectively, based on a meta-analysis of nine studies.

There is no significant difference in infection rates between uncemented and cemented TKAs, indicating that the fixation method does not influence the likelihood of infection.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Similar survival between uncemented and cemented fixation prostheses in total knee arthroplasty: a meta-analysis and systematic comparative analysis using registers. Wang, H., Lou, H., Zhang, H., et al.[2021]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4842397/

Cementless total knee arthroplasty - PMC Recent short-term trials have demonstrated that modern cementless TKA has comparable survivorship and functional outcomes as cemented prostheses.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9693456/

The Evolution, Current Indications and Outcomes of ... Overall, cemented and cementless TKA have great results in modern times and there is still a debate as to which implant is superior. Keywords: ...

3. arthroplastyjournal.org arthroplastyjournal.org/article/S0883-5403(23)00122-5/fulltext

Cementless Total Knee Arthroplasty Over the Past Decade Kaplan–Meier survivorship free from aseptic loosening was 99% (95% confidence interval 98 to 100) at a maximum of 10 years. Conclusion. These ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT06929871

Study Details | NCT06929871 | Mako Cementless TKA vs ... Findings of this study will enable an improved understanding of the radiological, clinical and functional benefits of cementless fixation compared to cemented ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S0972978X2500114X

Cemented vs. uncemented total knee arthroplasty in obese ... However, only two studies demonstrated a statistically significant improvement in implant survival, reduced aseptic loosening, and lower revision rates with ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12031968/

Improved performance of cementless total knee ... Cementless TKA was reported to have lower revision rates in the most recent US and New Zealand annual reports when compared to cemented TKA.

7. arthroplastyjournal.org arthroplastyjournal.org/article/S0883-5403(24)00198-0/fulltext

Cementless Total Knee Arthroplasty: A Resurgence—Who, ... Cementless TKA provides durable biologic fixation and successful long-term results with improved operating room efficiency.

8. sciencedirect.com sciencedirect.com/science/article/pii/S2352344124000451

Cemented vs Cementless Robotic-Assisted Total Knee ... According to worldwide registry data pooled in a study in 2016, the 10-year risk of revision after total knee arthroplasty (TKA) is 5%, with aseptic loosening ...

9. josr-online.biomedcentral.com josr-online.biomedcentral.com/articles/10.1186/s13018-024-04966-8

Fixation options for total knee arthroplasty: a comprehensive ... Cemented fixation has long been regarded as the gold standard for TKA, boasting high survival rates over long-term follow-ups [6,7,8]. Non- ...